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CTRI Number  CTRI/2025/07/090379 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two irrigating Solutions to check the antimicrobial efficacy in primary Teeth 
Scientific Title of Study   Comparative evaluation of antimicrobial efficacy of sodium hypochlorite with and without etidronic acid as root canal irrigants in primary teeth.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Amulya.V 
Designation  post graduate  
Affiliation  The Oxford Dental College Bangalore 
Address  The oxford dental collage department of pediatrics and preventive dentistry, room no 8 Bommanahalli, Hosur Road, Bangalore
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  08748990540  
Fax    
Email  amulya.v685@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Amulya.V 
Designation  post graduate  
Affiliation  The Oxford Dental College Bangalore 
Address  The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  08748990540  
Fax    
Email  amulya.v685@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Sneharaj N  
Designation  reader  
Affiliation  The Oxford Dental College Bangalore 
Address  The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore
Bangalore
KARNATAKA
560068
India 
Phone  7259784347  
Fax    
Email  dr.sneharaj.n@gmail.com  
 
Source of Monetary or Material Support  
The oxford dental collage and hospital  
 
Primary Sponsor  
Name  Dr Amulya V  
Address  The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli Hosur Road, Bangalore, India 560068  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
sneharajn   Bommanahalli oxford dental collage  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AmulyaV  The oxford dental college   Department of pediatric and preventive dentistry,floor no 4 room no 8,The oxford dental college,Bommanahalli, Hosur Road, Bangalore
Bangalore
KARNATAKA 
08748990540

amulya.v685@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The oxford dental college Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children requiring endodontic treatment in primary teeth.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  etidronic acid  Etidronic acid, also known as etidronate or 1-hydroxyethylidene 1,1-biphosphonic (HEBP) is a weak chelator. It can be used to remove inorganic debris. It penetrates deep into the root canals to kill Enterococcus faecalis 
Comparator Agent  sodium hypochlorite  Sodium hypochlorite (NaOCl) is widely used irrigant in the endodontic treatment. It has antibacterial, proteolytic, dissolving and debriding properties. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Healthy children requiring endodontic treatment in primary teeth.
2. Primary teeth with at least two third of total root length remaining.
3. Presence of abscess/soft tissue swelling in relation to the involved tooth.
4. Co-operative children.
5. Spontaneous pain/ pain at night awakening the child at night.
 
 
ExclusionCriteria 
Details  1. Medically compromised children.
2. Children with any recent antibiotic exposure in the preceding 1 months will be excluded from the study.
3. children who have used antimicrobial mouthwashes in the preceding 1 months.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
microbial colonies will be counted using digital colony counter and expressed as colony forming unit (CFU) per millimetre  1year 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to assess the effect of adding etidronic acid on the smear layer removal and dentin integrity during root canal irrigation. This includes evaluating any changes in the structural properties of primary tooth dentin.  1year 6 months  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Forty children aged 5 to12 years who require endodontic treatment, visiting to the Department of Pediatric and Preventive Dentistry, will be selected for the study who meets the inclusion criteria.

The selected children will be divided into two groups of 20 children each:

Group I: NaOCl without HEBP.

Group II: NaOCl with HEBP.

Following administration of local anaesthesia with 2% lignocaine hydrochloride containing adrenaline at a concentration of 1:80000, isolation of the primary molars will be carried out using rubber dam or with cotton rolls in cases do not permit the placement of clamps for rubber dam isolation. Following isolation, the tooth surface,

rubber dam and clamp will be cleaned with a solution of 3% (v/v) hydrogen peroxide.  The coronal access cavity preparation will be performed using sterile burs (#8 round bur) (Dentsply), and the root canal will be minimally instrumented with K file (Dentsply) and pulp will be extirpated with sterile barbed broach (Dentsply). For each primary molar the largest canal in the upper molar (palatal canal) and lower molar (distal canal) will be selected for the collection of samples from the root canal. The orifice of the remaining canal will be sealed with Cavit (3M ESPE) in order to prevent any possible microbiological contamination during collection of the sample.

For each tooth two samples will be collected in order to assess the microbial count. Sample A: after pulp extirpation and before irrigation (baseline).

Sample B: after irrigation.

A sterile paper point (Metabiomed, India) will be introduced into the full length of the canal and retained in position for 1min to soak up the tissue fluid (sample A).6 The collected sample will be placed in sterile Eppendorf tubes containing a nutrient broth and immediately stored in ice box. The canals will be gently cleaned and shaped. The root canal will be alternatively irrigated with the allotted irrigant to the particular group using sterile syringe with 29-gauge side vented needle (NaviTip) after every step of instrumentation. Sample B will be obtained in the similar manner as described earlier after the irrigation.  The treated tooth will be flushed with normal saline to prevent the potential carryover of irrigants. Consequently, a sterile cotton pellet will be placed in the pulp chamber and restored with temporary restoration. The collected samples will be sent to a microbiological laboratory for microbial analysis and microbial colonies will be counted using digital colony counter and expressed as colony forming unit (CFU) per millimetre. The tooth will be subsequently obturated and restored.

 
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